Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients

NCT02853097 | Terminated DMC

• 3 other identifiers: 4P-15-4NCI-2016-00958P30CA014089
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in blood from patients with prostate cancer that does not respond to hormone therapy and has spread to other places in the body. Studying samples of blood from patients with prostate cancer may help doctors to learn more about the changes that occur in tumor cells over time and how they become resistant to anti-cancer drugs.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Change in AR-V7 presence

  Each of the 4 longitudinal cohorts will be analyzed separately (at least initially). Kaplan-Meier-like curves (likely adjusted for interval censoring) will be used to display the development of AR-V7 positivity. To complement the analysis of Cohort A, an exact logistic regression analysis will be used with the data from Cohort X with AR-V7 splice variant positivity as the dependent variable and time since start of ADT as the independent variable. Logistic regression will be used to assess the association between AR-V7 status at start of treatment and overall response to treatment.

  Baseline to 3 years

• Expression level of AR-V7 in serum cfRNA assessed by quantitative RT-PCR

  Detectable AR-V7 will be associated with a shortened duration of treatment benefit (ADT, abiraterone, enzalutamide, docetaxel). Each of the 4 longitudinal cohorts will be analyzed separately (at least initially). A regression analysis based on the Cox proportional hazards model (if proportional hazards holds) will be used to assess the association between AR-V7 and time to new treatment. Initially, only the baseline AR-V7 status will be used. Next, AR-V7 will be included as a time dependent covariate; the model used may be modified to accommodate competing risks (if too many switch treatment p

  Up to 3 years

• Time to start of another treatment

  Time from start of treatment until the time that the patient begins another therapy, assessed up to 3 years

Secondary Outcomes (2)

• Expression levels of AR-Vs (other than AR-V7) in serum cfRNA assessed by quantitative RT-PCR

  Up to 3 years

• Tumor response as measured by Prostate Cancer Working Group

  Up to 3 years

Study Arms (1)

Ancillary-Correlative (blood collection)

Patients undergo blood collection every 4-12 weeks during ADT, abiraterone, enzalutamide, or docetaxel treatment. Patients switched from ADT to either abiraterone or enzalutamide during the study will undergo phlebotomy every 6-12 weeks. Samples are analyzed for cfRNA, and cfDNA, AR-V7, and other AR-Vs via quantitative RT-PCR.

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo blood collection

Also known as: Cytologic Sampling

Ancillary-Correlative (blood collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (blood collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients at various points throughout androgen deprivation therapy and at the initiation of androgen deprivation therapy, enzalutamide, abiraterone and docetaxel with either computed tomography measurable or evaluable disease or arising prostate specific antigen disease

You may qualify if:

• A diagnosis of histologically confirmed prostate adenocarcinoma and falling into one of the following 5 groups:
• Currently receiving ADT (previously untreated for metastatic disease)
• These patients will be grouped into 3 cohorts: having received ADT for 3-6 months; for 1-2 years; and for \> 3 years
• Scheduled to begin treatment with ADT (previously untreated for metastatic disease)
• Scheduled to begin treatment with enzalutamide (castration resistant / has received ADT / may have received abiraterone)
• Scheduled to begin treatment with abiraterone (castration resistant / has received ADT / may have received enzalutamide)
• Scheduled to begin treatment with docetaxel (castration resistant / has received ADT / has received enzalutamide and/or abiraterone)
• Have been diagnosed with either hormone-naive or castrate-resistant metastatic disease
• Ability and willingness to provide written and informed consent

You may not qualify if:

• Patients who receive combined ADT with docetaxel for hormone-naive metastatic prostate cancer
• Patients on intermittent ADT

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jacek Pinski, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: June 14, 2016
• Primary Completion: September 27, 2020
• Study Completion: September 27, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (3)